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Completed

NCT Number: NCT05614609

Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial

Few studies have compared different methods for optimalizing intubation conditions in general anesthesia. This randomized controlled trial will compare two different methods for intubation in general anesthesia in gastro- or gynecological procedures.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann-Chatrin Linqvist Leonardsen

Kråkerøy, Østfold fylke, 1679, Norway

About this study

In general anesthesia, it is neccessary to secure the airways with an endotracheal tube. There is no international consensus on how intubation is most efficiently conducted. A cochrane review compared using muscular relaxing medication versus not using blocks for intubation. Primary outcomes were intubation conditions and discomfort in upper airways. The authors concluded that research is limited, and that further research is needed. No studies have compared local anesthetic spray on the glottis and muscular relaxing medication in intubation, focusing on discomfort in upper airways. The null-hypothesis of this study is that there is no difference in upper airway discomfort when using local anesthetic spray or muscular relaxing medication. The study will have a randomized controlled design, randomizing patients undergoing gastro- or gynecological procedures in general anesthesia to receiving either rocuronium (muscle relaxing medication) intravenous, or lidocain spray on the glottis before intubation. The primary outcome is postoperativ hoarseness one hour after intubation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA (American Association of Anesthesiologists Classification system for physical status) I-III
  • Understand and can express themselves in Norwegian
  • Able to give informed consent to participate

Exclusion criteria

  • Cave lidocain and/or muscle relaxing medication
  • BMI above 40
  • Anticipated difficult intubation
  • Need for ventricular tube
  • Pathology or malformations in upper airways

Treatment and study plan

Lidocaine topical

Drug

Comparing lidocaine spray and muscle relaxing medication

Other names: Rocurinoum 0.6 mg/kg intravenous

Primary outcomes

  1. Degree of hoarseness 1 hour after extubation

    Time frame: 1 hours

    Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia

Secondary outcomes

  1. Intubation conditions

    Time frame: Before intubation

    Cormack & Lehane four degrees

  2. Number of intubation attempts

    Time frame: At intubation

    Number

  3. Number of patients needing extra equipment for intubating

    Time frame: At intubation

    bourgie, c-mac, other

  4. Proportion of patients who cough when spraying

    Time frame: At intubation

    yes/no

  5. Proportion of patients with normal anatomy in upper airways

    Time frame: At intubation

    yes/no

  6. Blood pressure changes during intubation

    Time frame: at intubation

    Blood pressure before and 2 minutes after intubation

  7. Heart rate changes during intubation

    Time frame: at intubation

    Heart rate before and 2 minutes after intubation

  8. Proportion of patients who cough on tube at extubation

    Time frame: At extubation

    yes/no

  9. Proportion of patients with blood on tube after extubation

    Time frame: At extubation

    yes/no

  10. Degree of hoarsness 24 and 48 hours after extubation

    Time frame: 2-48 hours

    Scored on a scale : 0=no, 1= self reported hoarseness, 2=observed hoarsness by care personnel, 3=aphonia

  11. Proportion of patients reporting different degrees of sore throat at 2, 24 and 48 hours after extubation

    Time frame: 2-48 hours

    0=no, 1=mild, 2=moderate, constant pain when swallowing, 3=severe pain needing analgesia

Sponsors and collaborators

Lead sponsor

Ostfold University College

Other

Registry information

Official study title

Discomfort in Upper Airways Due to intubation-a Randomized Controlled Trial in a Norwegian Hospital

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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